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ISO 13485

 ISO 13485
ISO 13485

ISO 13485:2003 Quality Management System for Medical Devices


ISO 13485:2003 Quality Management System for Medical Devices SO 13485 is a Management Systems Standard specifically developed for the manufacture of Medical Devices published by International Organization for Standardization in 2003. The standard provides a framework for a comprehensive management system for the design and manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain.

It is especially relevant to manufacturers who wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.


Essentials of ISO 13485:2003 -

Implementation of a Quality Management System with several enhancements Risk Management approach to product development and product realization Validation of processes Compliance with statutory and regulatory requirements Effective product traceability and recall systems

Benefits of ISO 13485:2003 -


Customer satisfactionReduced operating costs Improved stakeholder relationships Legal compliance Improved risk management Proven business credentials Ability to win more business

Our Services:


We offer comprehensive services that will help you achieve your ISO 13485:2003 quality goals. We provide assistance to:


Conduct an initial gap analysis Help you establish policies and objectives Identify documentation requirements Make assignments and prepare schedules Prepare documentation Coordinate document preparation, reviews, approvals, and production Manage implementation schedules, training, follow-up actions Help you seek accreditation certificate for ISO 13485:2003

 


In addition to consulting (online & onsite), we provide following training:


ISO 13485 Overview Training ISO 13485 for the Small LaboratoryDeveloping Medical Devices Quality System Documentation Internal Auditor training ISO 13485 implementation training

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ISO 13485 certificate Consultants for ISO 13485 certification QMS in UAE Abu Dhabi, Dubai, Sharjah, Ajman, Umm al-Quwain, Ras al-Khaimah & Fujairah

Consultants for ISO 13485 standards, ISO 13485 implementation, ISO 13485 training, ISO 13485 documentation and ISO 13485 certification in uae duabi abu dhabi.